Thrombolysis and RIPC in Acute Ischemic Stroke (tripcais)

The Recovery of Nerve Function Deficient of Combined Intravenous Thrombolysis and Remote Ischemic Post-conditioning in Acute Ischemic Stroke.

Remote ischemic postconditioning (RIPC) is suggested to protect the cerebral cell against ischemia in various settings. However, the effect of RIPC in patients with acute ischemic stroke who undergo thrombolysis has yet to be examined. In this single-center, randomized controlled trial, we examined the effect of RIPC on the resolution of nerve function deficient in response to thrombolysis. Patients in the RIPC group had five cycles of 5-min cuff inflation followed by 3-min deflation to the bilateral upper arm after thrombolysis. The primary endpoint was the recovery of nerve function deficient assessed by National Institutes of Health Stroke Scale(NIHSS), Activities of Daily Living(ADL), Modified Rankin Scale(mRS), CT cerebral perfusion imaging (CTP) and CT angiography(CTA). Secondary endpoints included the following: angiogenesis assessed by the level of vascular endothelial growth factor (VEGF), basic fibroblast growth factor (bFGF).

Study Overview

• Status: Completed
• Conditions: Acute Ischemic Stroke, Cerebral Embolism and Thrombosis
• Intervention / Treatment: Device: RIPC device (IPC-906X)

• Study Type: Interventional
• Enrollment (Actual): 68
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Xi'an, China, 710061
    • The First Affiliated Hospital of Xi'an Jiaotong University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• In accordance with the Guideline of Thrombolysis in Acute Ischemic Stroke and accomplish intravenous thrombolytic therapy using alteplase;
• The consciousness of patients are conscious,somnolence,confusion and stupor，can comply better with the RIPC treatment;
• Acute ischemic stroke confirmed by cranial CT/MRI;
• Provision of written informed consent.

Exclusion criteria:

• History of cerebral embolism,cerebral hemorrhage, brain tumor, brain trauma or other brain lesion;
• Severe cardiac, liver, or kidney disease, malignancy, systemic organ dysfunction;
• Blood pressure <90/60 mmHg or >200/110 mmHg after treatment;
• Dementia or mental illness;
• History of major surgery or trauma 4 weeks prior to admission;
• Failure to provide informed consent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: RIPC; Remote ischemic postconditioning（RIPC）：Patients in the RIPC group not only receive foundational treatment but also have five cycles of 5-min cuff inflation followed by 3-min deflation to the bilateral upper arm using a RIPC device (IPC-906X; Beijing Renqiao Institute of Neuroscience, Beijing, China) after thrombolysis while in-hospital.	Device: RIPC device (IPC-906X); Patients in the RIPC group had five cycles of 5-min cuff inflation followed by 3-min deflation to the bilateral upper arm after thrombolysis.; Other Names: Thrombolysis
No Intervention: Blank control group(BC); Blank control group:Patients in the BC group only receive foundational treatment, including free radical elimination in the acute stage, blood pressure and blood glucose stabilization, and antiplatelet (aspirin, 100-300 mg/d) and lipid-lowering (atorvastatin, 20 mg/d) drugs,throughout the 14 days in-hospital period without remote ischemic postconditioning after thrombolysis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
the percentage of patients with a favorable outcome, defined as a score of 0 or 1 on the modified Rankin scale (mRS).	Day 90

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the percentage of functional recovery at discharge and at day 90, as measured by the NIHSS, the Barthel index (BI) and the mRS	we measured how many patients achieved a score of 0 or 1 for the NIHSS, 95 for the BI, and 0 - 2 for the mRS.	Day 90 and at discharge(up to day 14)
Plasma biomarker concentrations	Venous blood was drawn before the administration of IV tPA and at the end of hospitalization to determine the effect of repeated RIPC on anti-inflammatory (S100-β), vascular (VEGF, bFGF), anti-edema (MMP9), anti-oxidants (OH1) and other pathways (BDNF, HSP).	Day 1 and at discharge ( up to day 14)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
mortality rate	three-month mortality rate	up to 3 months.
the rate of symptomatic hemorrhagic transformation	Defined by European Cooperative Acute Stroke Study III classification	up to 36 hours
Early neurological deterioration		up to 24 hours after IV tPA
The tolerance index	the proportion of patients that could complete every RIPC treatment session during his/her hospital stay.	up to 14 days

Collaborators and Investigators

• Sponsor: First Affiliated Hospital Xi'an Jiaotong University
• Investigators: Principal Investigator: Guogang Luo, MD, PhD, First Affiliated Hospital Xi'an Jiaotong University

Publications and helpful links

General Publications

• An JQ, Cheng YW, Guo YC, Wei M, Gong MJ, Tang YL, Yuan XY, Song WF, Mu CY, Zhang AF, Saguner AM, Li GL, Luo GG. Safety and efficacy of remote ischemic postconditioning after thrombolysis in patients with stroke. Neurology. 2020 Dec 15;95(24):e3355-e3363. doi: 10.1212/WNL.0000000000010884. Epub 2020 Oct 7.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2017
• Primary Completion (Actual): October 31, 2020
• Study Completion (Actual): October 31, 2020

Study Registration Dates

• First Submitted: July 6, 2017
• First Submitted That Met QC Criteria: July 12, 2017
• First Posted (Actual): July 14, 2017

Study Record Updates

• Last Update Posted (Actual): August 23, 2021
• Last Update Submitted That Met QC Criteria: August 19, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Necrosis; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Ischemia; Infarction; Brain Infarction; Thromboembolism; Stroke; Ischemic Stroke; Embolism; Ischemia; Thrombosis; Cerebral Infarction; Embolism and Thrombosis; Intracranial Embolism; Intracranial Embolism and Thrombosis
• Other Study ID Numbers: XJTU1AF-CRF-2016-013

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No